FDA.reportPublic FDA data

caffeine citrate

Product NDC
25021-602
11-digit product format
250210602
Labeler code
25021
Product ID
25021-602_059be7d2-16bf-4197-a4b2-5a05540d6b82
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
caffeine citrate
Dosage form
SOLUTION
Route
ORAL
Labeler
Sagent Pharmaceuticals
Application
ANDA091102
Marketing category
ANDA
Marketing start
2012-09-15
Substance
CAFFEINE CITRATE
Active strength
20 mg/mL
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
caffeine citrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAFFEINE CITRATE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU26EO4675Q
Rxcui849928, 849931

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-602-03caffeine citrate3 mL in 1 VIALSOLUTION39
25021-602-03caffeine citrate10 in 1 CARTONSOLUTION109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-602-03ML - Milliliter25021-6026424bf96-ef29-43f9-803f-82fbd970a1e312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
caffeine citrateACTIVE INGREDIENTU26EO4675QCAFFEINE CITRATE SOLUTION [SAGENT PHARMACEUTICALS]6
caffeineACTIVE MOIETY3G6A5W338ECAFFEINE CITRATE SOLUTION [SAGENT PHARMACEUTICALS]6
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPCAFFEINE CITRATE SOLUTION [SAGENT PHARMACEUTICALS]6
trisodium citrate dihydrateINACTIVE INGREDIENTB22547B95KCAFFEINE CITRATE SOLUTION [SAGENT PHARMACEUTICALS]6
waterINACTIVE INGREDIENT059QF0KO0RCAFFEINE CITRATE SOLUTION [SAGENT PHARMACEUTICALS]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-602CAFFEINE CITRATE SOLUTION [SAGENT PHARMACEUTICALS]8Current NDC, Legacy NDC, 2 package rows20210126_5f38c395-0093-4afd-89ec-f96e5dc0934a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849931caffeine citrate 60 MG in 3 ML InjectionPSN5f38c395-0093-4afd-89ec-f96e5dc0934a9
849928caffeine citrate 60 MG in 3 mL Oral SolutionPSN5f38c395-0093-4afd-89ec-f96e5dc0934a9
8499313 ML caffeine citrate 20 MG/ML InjectionSCD5f38c395-0093-4afd-89ec-f96e5dc0934a9
849928caffeine citrate 20 MG/ML Oral SolutionSCD5f38c395-0093-4afd-89ec-f96e5dc0934a9
849931caffeine citrate 20 MG/ML (caffeine base 10 MG/ML) InjectionSY5f38c395-0093-4afd-89ec-f96e5dc0934a9
849931caffeine citrate 60 MG per 3 ML InjectionSY5f38c395-0093-4afd-89ec-f96e5dc0934a9
849928caffeine citrate 60 MG per 3 ML Oral SolutionSY5f38c395-0093-4afd-89ec-f96e5dc0934a9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-602-032502106020310 VIAL in 1 CARTON (25021-602-03) / 3 mL in 1 VIAL10 vial2012-09-150000-00-00NoNoCurrent